Vertex Announces Plans for 2nd CGT Research and Manufacturing Facility in Boston
Vertex is doubling down on cell and genetic therapy R&D. Having recently opened a 400-person center in Boston, the biotech has set out plans for a 344,000-square-foot facility just around the corner. The expansion will mark another significant step up in Vertex’s R&D and manufacturing capabilities for cell and genetic therapies. At the first site, 70% of which is dedicated to lab and research space, Vertex is installing 400 employees to work on advanced therapies for conditions including sickle cell disease, beta thalassemia, Type 1 diabetes and Duchenne muscular dystrophy. Vertex shared details of the new facility at an event to dedicate the first site, which is now called the Jeffrey Leiden Center for Cell and Genetic Therapies after the biotech’s executive chairman. A new cell and genetic therapies research and manufacturing facility, dubbed Leiden II, will accommodate up to an additional 500 employees. Learn More
Big Biopharma’s Biggest Spenders Revealed
The world’s largest drug developers invested a combined $183 billion on R&D, M&A and licensing deals in 2021. While this is a huge sum, it also represents a fairly sizeable dip versus the previous two years. A jump in spending on in-house development last year – boosted by Covid-related R&D bills – failed to offset a pullback in deal-making. Signs are growing that 2022 could be another down year for these sector giants, with much pandemic-related clinical work ending and a muted start to the year for big pharma’s business development teams. A review of the data finds that Bristol Myers Squibb has spent the most on M&A, R&D and licensing since 2017, and Eli Lilly the least. Learn More
What Happens When the Government Stops Buying Covid-19 Vaccines?
The federal government has distributed Covid-19 vaccines and treatments for free so far, but most likely, the handouts won’t last forever. At some point, Covid-19 vaccines and treatments will be bought and sold just like other drugs and medical products. But big questions loom about how and when the transition will happen, about how bumpy it will be. The issue has gained urgency in recent weeks as Congress has been reluctant to provide the Biden administration with any additional funds to combat the Covid-19 pandemic. That means the government is out of money to purchase more vaccines, oral antivirals, and therapeutics, not to mention next-generation vaccines and therapies tailored to particular variants. Learn More
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Quote Alert
On This Day Alert
2001 - The Comedy "Shrek" is Released Nationwide in the United States
Shrek is a 2001 American computer-animated comedy film loosely based on the 1990 fairy tale picture book of the same name by William Steig. The film parodies other fairy tale adaptations, primarily aimed at animated Disney films. The story follows the titular Shrek, an ogre who finds his swamp overrun by fairy tale creatures who have been banished by the corrupt Lord Farquaad aspiring to be king. Shrek makes a deal with Farquaad to regain control of his swamp in return for rescuing Princess Fiona, whom Farquaad intends to marry. With the help of Donkey, Shrek embarks on his quest but soon falls in love with the princess, who is hiding a secret that will change his life forever. Learn More
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TED Alert
Animations of Unseeable Biology
We have no ways to directly observe molecules and what they do -- Drew Berry wants to change that. At TEDxSydney he shows his scientifically accurate (and entertaining!) animations that help researchers see unseeable processes within our own cells. Learn More
Poll Alert
Do you believe the COVID-19 virus was originally created in a lab?
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Bioprocess Alert
Multi Attribute Method Implementation Using a High-Resolution Mass Spectrometry Platform: From Sample Preparation to Batch Analysis
Quality control of biopharmaceuticals such as monoclonal antibodies (mAbs) has been evolving and becoming more challenging as the requirements of the regulatory agencies increase due to the demanding complexity of products under evaluation. Mass Spectrometry (MS)-based methods such as the multi-attribute method (MAM) are being explored to achieve a deeper understanding of the attributes critical for the safety, efficacy, and quality of these products. MAM uses high mass accuracy/high-resolution MS data that enables the direct and simultaneous monitoring of relevant product quality attributes (PQAs, in particular, chemical modifications) in a single workflow, replacing several orthogonal methods, reducing time and costs associated with these assays. Learn More
Cell Viability Assessment Associated with a Contact of Gas Bubbles Produced by Femtosecond Laser Breakdown in Cell Culture Media
High intensity near infrared femtosecond laser is a promising tool for three-dimensional processing of biological materials. During the processing of cells and tissues, long lasting gas bubbles randomly appeared around the laser focal point, however physicochemical and mechanical effects of the gas bubbles has not been emphasized. This paper presents characteristic behaviors of the gas gabbles and their contact effects on cell viability. High-speed imaging of the gas bubble formation with various additives in physiological medium confirms that the gas bubble consists of dissolved air, and amphipathic proteins stabilize the bubble surface. This surface protective layer reduces interactions of gas bubbles and cell membranes. Learn More
Studio Science - A Virtual Demo of Resolute® AutoPak for Automated Column Packing
Wednesday, May 18th, 2022
David Gates, Product Specialist, Chromatography Hardware in Europe
Full automation is the only way forward for large-scale packed bed chromatography, but not all automated systems deliver the same levels of performance. Resolute® Linear columns with the AutoPak system deliver fully automated packing, repacking, unpacking and clean-in-place (CIP) operations, which greatly reduces operator error and allows for robust, predictable processing. This broadcast session reviews the AutoPak system and how it works to fully automate column preparation. Learn More
Challenges in Predictive Modeling of Single Pass Tangential Flow Filtration for Continuous Biomanufacturing
Opportunities for process intensification and increased productivity have made the field of Continuous Biomanufacturing an area of high interest and active research. Our work elucidates the development of a mechanistic process model to predict SPTFF performance across a relatively wide design space using a first principles approach. The developed model is found to be accurate for a range of high feed flow rates but is inaccurate at flow rates below 25 L/m2/hr. At very low flow rates, small differences in the mass transfer coefficient have been observed to significantly alter the prediction of the retentate concentration. We thus describe the challenges in predictive process modeling of SPTFF in antibody biomanufacturing. Learn More
Vanquishing Parkinson's Disease, Jim Sullivan, PhD, Co-founder & CEO, Vanqua Bio
Dr. Sullivan is co-founder and CEO of Vanqua. In addition, he has been a Venture Partner with Orbimed since January 2019. Previously, he was the Vice President of Research at Abbvie where he was responsible for the company’s research efforts in a variety of therapeutic/disease areas including oncology, immunology, neurology, hepatitis C and cystic fibrosis. Jim has advanced more than 100 compounds into clinical development across a number of disease states and technology platforms. Learn More
The Development of Thin-Film Freezing and Its Application to Improve Delivery of Biologics as Dry Powder Aerosols
Thin-film freezing (TFF) is a new cryogenic technique that can engineer highly porous, brittle, powder matrices with excellent aerosol performance properties and stability. Herein, we describe TFF in comparison to other cryogenic techniques. Physical properties of TFF powders such as morphology, moisture sorption, stability, solubility, and dissolution, as well as aerosol properties are discussed. In addition, factors that significantly affect the physical and aerosol properties of dry powders prepared by TFF, such as solids content, drug loading, solvent system, excipient, and dry powder delivery device, are analyzed. Finally, we provide evidence supporting the applicability of using TFF to prepare dry powder formulations of protein-based pharmaceuticals, enabling their cold chain-free storage as well as efficient pulmonary delivery. Learn More
FDA, EMA Officials Discuss Impediments to Cell and Gene Therapies
The US FDA’s top biologics regulator said the use of a “playbook” or platform approach for developing multiple cell and gene therapy products and a globally harmonized template would facilitate the development of such products at a meeting this week of the American Society of Gene and Cell Therapy (ASGCT). Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research (CBER) and Ana Hidalgo-Simon, head of advanced therapies at the European Medicines Agency (EMA), also agreed that manufacturing and reimbursement challenges are impeding the development of these products. At the meeting, the regulators were asked to address why there have not been more approvals of these products, and their suggestions for ushering more of these therapies to market. Learn More
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Discovery Alert
mRNA Vaccines Like Pfizer and Moderna Fare Better Against COVID-19 Variants of Concern
A comparison of four COVID-19 vaccinations shows that messenger RNA (mRNA) vaccines -- Pfizer-BioNTech and Moderna -- perform better against the World Health Organization's variants of concern (VOCs) than viral vector vaccines -- AstraZeneca and J&J/Janssen. Although they all effectively prevent severe disease by VOCs, the research, publishing May 17 in the open access journal PLOS Medicine, suggests that people receiving a viral vector vaccine are more vulnerable to infection by new variants. Learn More
Project Alert
Novato Advances Plans to Expand Biotechnology Complex
Novato is looking to enhance its status as a North Bay biotechnology hub under a proposal that could double the footprint of its life sciences campus near the Bel Marin Keys. City officials and a group of companies have been working since 2016 to plan further expansion to the 200-acre campus along northbound Highway 101 near Ignacio Boulevard. A proposal set to go before the city council on May 24 would allow for larger, taller warehouses, laboratories, offices, and construction buildings than is currently allowed. The Novato Planning Commission voted unanimously on Monday and recommended that the city council approve the plan. Learn More
Method for Large Scale Production of Antibodies Using a Cell Free Protein Synthesis System
A U.S. Patent Application for a "Method for Large Scale Production of Antibodies Using a Cell Free Protein Synthesis System" from Sutro Bio was published on March 24th, 2022. The present invention are methods for large scale production of antibodies using a cell-free protein synthesis system. The methods include expressing a heavy chain (HC) polypeptide of an antibody from a nucleic acid encoding the heavy chain in a cell-free bacterial extract in the presence of a light chain (LC) polypeptide, thereby producing the antibody. The methods are performed at a large scale that is suitable for commercial production of antibodies, for example in a reaction volume equal to or greater than about 10 liters, for example about 10 to about 25,000 liters. Learn More
Compliance of Palltronic Flowstar V Filter Test Instrument with Data Integrity Requirements
Assuring the integrity of records when generating and maintaining them is essential to the development and production of high-quality, safe, and effective drugs. This white paper reviews the US and European regulations, and details how records generated by the Palltronic Flowstar V integrity test instrument meets the requirements. Learn More
Shrek's Voice and Accent Changes Cost the Studio $38M
Chris Farley began to voice Shrek before his untimely death, with roughly 85% of his lines recorded, the movie fell apart and even though actual animation hadn't even started, it cost the studio roughly $34M. Later, when Mike Myers went on to define the role, Shrek was given a thick Canadian accent, but after animation had begun, Meyers decided a Scottish accent would be better. The film had to be re-animated and cost over $4M, but can you imagine Shrek any other way? Learn More
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Career Alert
Merck Scientist, Vaccines Process Research & Development West Point, PA
The successful candidate will serve as an individual scientific contributor responsible for downstream process development of vaccine candidates encompassing multiple modalities including live/attenuated viruses, nucleic acids, recombinant protein subunits, and polysaccharide-protein conjugates. Learn More
Pfizer Principal Scientist– Fermentation Process Development Kalamazoo, MI
The position will work as part of an interdisciplinary team as well as providing scientific leadership to improve Pfizer’s production processes through biotransformation, biocatalysis and microbial culture improvement projects Learn More
Just-Evotec Biologics MES/Automation Engineer/Sr. Engineer – Technical Operations Redmond, WA The MES/Automation engineer will be part of the Manufacturing Automation team in the Technical Operations organization to support the management and expansion of the PAS-X Manufacturing Execution System used for clinical and commercial manufacturing at Just-Evotec Biologics. Learn More
Eikon Therapeutics
Research Associate, Cell Culture Hayward, CA
As a cell culture research associate or senior research associate, you will execute cell culture processes to support our technology platform. Primary responsibilities include mammalian cell culture maintenance, expansion and banking for several research programs and HTP automated screening. Learn More
